Treatment of Chronic Wounds in Diabetic Foot Syndrome With Allogeneic Adipose Derived Mesenchymal Stem Cells
NCT ID: NCT03865394
Last Updated: 2021-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
46 participants
INTERVENTIONAL
2019-07-01
2021-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Allogeneic ADSC cells in fibrin solution
Application of allogeneic ADSC stem cells in fibrin gel, to cover wound surface with thin cells layer.
Therapy is based on standard procedure of diabetic foot ulcer treatment combined with application of allogeneic ADSC stem cells in fibrin solution onto the wound surface.
Application of allogeneic ADSC stem cells in fibrin gel
Chronic wounds in diabetic foot ulcer will be covered with ADSC suspended in fibrin gel - single dose will be administered followed by weekly wound control.
Standard care in diabetic foot ulcer with aplication of fibrin gel to cover wound surface.
Application of fibrin gel to cover wound surface.
Standard care in diabetic foot ulcer
Chronic wounds in diabetic foot ulcer will be covered with fibrin gel followed by weekly wound control.
Interventions
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Application of allogeneic ADSC stem cells in fibrin gel
Chronic wounds in diabetic foot ulcer will be covered with ADSC suspended in fibrin gel - single dose will be administered followed by weekly wound control.
Standard care in diabetic foot ulcer
Chronic wounds in diabetic foot ulcer will be covered with fibrin gel followed by weekly wound control.
Eligibility Criteria
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Inclusion Criteria
2. Above the age of 18
3. Voluntary participation in the research, following the requirements of the protocol and acceptance for procedures related with its implementation
4. Chronic wound in the course of diabetic foot syndrome, with the wound surface between 1 - 25 sq. cm, without evidence of active infection of the wound at the time of qualification to participate in the study
5. Blood level of glycated haemoglobin (HbA1c) \<=11%
6. Satisfactory blood supply to the wound verified by the measurement of the oxygen level in the foot tissue (\>=30 mmHg), or by the measurement of systolic blood pressure in posterior or anterior tibial artery (\>=50 mmHg) of the affected limb.
7. General health condition, which according to the investigator's opinion, allows patient's participation in all study procedures.
Exclusion Criteria
2. Wound etiology other than diabetic foot syndrome
3. Clinicaly significant limb ischemia as verified by the measurement of the oxygen level in the foot tissue (\<30 mmHg), or by the measurement of systolic blood pressure in posterior or anterior tibial artery (\<50 mmHg)
4. Active wound infection, which would require the treatment with antibiotics
5. Known allergy to ingredients of study product (thrombin, penicillin).
6. Active venous thromboembolism
7. Any systemic disease (acute or chronic) in the stage of exacerbation or not stabilized, that in the opinion of the investigator may hinder or make impossible a patient's participation in the study
8. Active cancer during chemotherapy or radiotherapy, or recent cancer, if the remission occured less than 5 years before joining the study
18 Years
ALL
No
Sponsors
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Polish Stem Cells Bank S.A.
UNKNOWN
Medical University of Warsaw
OTHER
Responsible Party
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Principal Investigators
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Beata Mrozikiewicz-Rakowska, . Assoc.Prof.
Role: PRINCIPAL_INVESTIGATOR
Medical University of Warsaw, Department of Diabetology and Internal Diseases
Locations
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Medical University of Warsaw, Department of Diabetology and Internal Diseases
Warsaw, , Poland
Countries
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Other Identifiers
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267976/13/NCBR/2015
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2016-004109-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
PL008125
Identifier Type: OTHER
Identifier Source: secondary_id
Z4217
Identifier Type: OTHER
Identifier Source: secondary_id
1ABC Therapy
Identifier Type: -
Identifier Source: org_study_id